Quality Assurance Specialist/Document Control – BioCryst Pharmaceuticals

Job Title: Quality Assurance Specialist/Document Control
Department: Quality Assurance
Location: Durham, NC
 
JOB SUMMARY
The Quality Assurance Specialist/ Document Control at BioCryst Pharmaceuticals, Inc. is responsible for ensuring the BioCryst Document Control System is managed in compliance with BioCryst’s SOPs and Quality Systems. Reporting to the Director of Quality Assurance, the QA Specialist/Document Control will be based at BioCryst’s Durham, NC site. This position is responsible for managing and administering the Document Control systems to ensure compliance to applicable internal procedures, cGMPs, and regulatory requirements. This position will also be responsible for managing and maintaining the BioCryst training program related to the controlled documents and internal training. Functions include QA support for change control, deviations, investigations, document control, training, validation, internal audits, regulatory inspections, vendor management, clinical QA audit tracking and management.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES

• Serves as primary Document Control/EDMS administrator
• Works independently to manage and administer effective Document Control systems ensuring compliance to applicable internal procedures, cGMPs, and regulatory requirements
• Works with QA Director to establish and execute Document Control Procedures
• Supports review, update, filing and distribution of controlled documents, including standard operating procedures, standard test methods, protocols, summary reports, and technical documents according to specific DCO format standards and guidelines
• Creates and maintains document templates
• Ensures controlled documents conform with applicable procedures and are maintained to latest revisions; reviews formats for consistency
• Responsible for timely distribution of draft and final controlled documents
• Coordinates the approval process and orderly upload and filing of controlled documents to SharePoint
• Supports controlled document life cycle/retention procedures
• Manages Biennial Review and Document Change Control Programs
• Performs proofreading, editing, word processing, and filing to support the Quality Assurance, Documentation, Batch Record, and Audit/Inspection functions
• Creates and maintains filing systems (electronic and paper) for all controlled documents
• Organizes and maintains QA Document Room and Batch Release documentation relative to projects
• Maintains Deviation, CAPA, and Change Control database/records, SOP Master List, and document number issuance logs for controlled documents
• Manages employee training program and periodic review of all training files
• Updates Training Matrices for all GXP employees; creates and maintains employee training files; assists with group training
• Assists with Vendor Management Program – maintains database and tracks due dates for audit reports, vendor re-assessments
• Manages Records Retention/Archiving, ensuring adherence to specific records retention schedules
• Writes SOPs related to document control/document management
• Assists with internal audits and regulatory inspections
• Provides cross-functional support within QA department, as needed
• Perform other duties as assigned by QA Director
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules
• Maintains an awareness of evolving industry standards for document generation and electronic document management

 
DESIRED EDUCATION/EXPERIENCE/SKILLS

• Bachelors’ degree or Associate Degree or equivalent and 3-5 years’ experience in document processing/document management in a biotech, pharmaceutical, or contract research organization
• 5+ years’ experience in small or large biotech/pharmaceutical environment
• 3+ years’ experience in managing a document system
• Experience in Document Control, CAPA, Change Control, and Training systems
• Possess strong technical computer skills with proficiency in using various computer programs and web-based applications, including Microsoft Word. Excel, PowerPoint, One Drive, SharePoint.
• Team player with strong attention to detail
• Ability to work under pressure with tight deadlines
• Ability to maintain confidentiality and work with sensitive documents
• Interpersonal skills – ability to interact well with colleagues at all levels
• Strong organizational skills
• Adapts to changing priorities effectively
• Ability to work independently on assignments
• Good problem-solving skills
• Knowledge of FDA regulations and industry standard guidelines for electronic records; i.e., 21 CFR Part 11
• Demonstrate ethical conduct, focus on goals, take ownership of actions, and act in the best interest of the Company.

 
TECHNICAL SKILLS

• Knowledge of US FDA and European GMP requirements and associated guidelines
• Team player committed to quality; motivated self-starter; detail and results oriented; well organized, efficient worker with good communication skills
• Strong written and oral communication skills; ability to manage multiple projects at one time
• Possess strong technical computer skills with proficiency in using various computer programs and web-based applications, including Microsoft Word. Excel, PowerPoint, One Drive, SharePoint.

 
Interested candidates should submit their resumes to: Human_Resources(at)biocryst.com.
 
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
 
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local laws.